ModifiedCentenePolicy CP.PHAR.198

Tadalafil (Adcirca, Alyq, Tadliq) — Coverage Criteria for Pulmonary Arterial Hypertension

Defines medical necessity and prior authorization criteria for tadalafil (Adcirca, Alyq, Tadliq) for treatment of pulmonary arterial hypertension (PAH) for members under Centene lines of business.

Policy Summary

PayerCentene

PolicyTadalafil (Adcirca, Alyq, Tadliq) — Coverage Criteria for PAH

Policy CodePolicy CP.PHAR.198

Change TypeMaterial updates: new formulation, dosing updates, IL HIM bypass, approval duration changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of PAH diagnosis, specialist involvement, prior calcium channel blocker failure (unless exception), and adherence to dosing and quantity limits.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for IL HIM per IL HB 5395 and requirement that request does not exceed health-plan approved quantity limit; extended Medicaid and HIM initial approval duration from 6 months to 12 months for this maintenance medication.

Newly approved oral suspension formulation Tadliq added to policy and dosing regimens updated.

Criteria clarified to also apply to brand Adcirca, Alyq, and Tadliq; commercially unavailable branded products removed from Appendix B.

40 mg/daymax daily dose

20 mg/5 mLTadliq concentration

20 mgtablet strength

Requiredstep therapy

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12 monthsMedicaid/HIM approval

WHO Group 1FDA indication

Coverage Criteria for Tadalafil (Adcirca, Alyq, Tadliq)

Initial Approval — Pulmonary Arterial Hypertension

Covered when ALL of the following are met:

Initial PAH criteria: 1. Member has a diagnosis of pulmonary arterial hypertension (PAH, WHO Group 1). 2. Medication is prescribed by or in consultation with a cardiologist or pulmonologist. 3. Failure of a calcium channel blocker (see Appendix B), unless member meets one of the following exceptions: (a) inadequate response or contraindication to acute vasodilator testing; or (b) contraindication to or clinically significant adverse effects from calcium channel blockers. 4. If the request is for brand Adcirca, Alyq, or Tadliq, the member must use generic tadalafil unless contraindicated or clinically significant adverse effects are experienced, OR for Tadliq requests the member is unable to swallow tablets (Note: for Illinois HIM requests, step therapy requirements do not apply to Tadliq per IL HB 5395). 5. Request does not exceed the health-plan approved quantity limit. 6. Dose does not exceed one of the following: (a) Adcirca/Alyq: maximum 40 mg per day and maximum 2 tablets per day; or (b) Tadliq: maximum 2 bottles per month and maximum 300 mL per month.

Continuation (Renewal) Approval — Pulmonary Arterial Hypertension

Covered when ALL of the following are met:

Continuation criteria: 1. Member meets one of the following: (a) currently receiving the medication via the Centene benefit or has previously met initial approval criteria; or (b) currently receiving the medication and enrolled in a state/product with continuity of care regulations. 2. Member is responding positively to therapy. 3. If the request is for brand Adcirca, Alyq, or Tadliq, the member must use generic tadalafil unless contraindicated or clinically significant adverse effects are experienced, OR for Tadliq requests the member is unable to swallow tablets (Note: for Illinois HIM requests, step therapy requirements do not apply to Tadliq per IL HB 5395). 4. Request does not exceed the health-plan approved quantity limit. 5. If the request is for a dose increase, the new dose does not exceed the dosing limits specified: (a) Adcirca/Alyq: maximum 40 mg per day and 2 tablets per day; or (b) Tadliq: maximum 2 bottles per month and 300 mL per month.

Other diagnoses/indications

If requested use is not the FDA-approved PAH indication:

Off-label or recent label-change handling: 1. If the drug label changed within the last 6 months and that change is not yet reflected in this policy (e.g., new indication, age expansion, or new dosing), refer to the appropriate no-coverage or non-formulary policy for the relevant line of business. 2. If the requested use (diagnosis, age, dosing) is not listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and criterion 1 above does not apply, refer to the applicable off-label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, CP.PMN.53 for Medicaid).

Operational coverage notes (dosing, availability, duration, brand applicability)

Coverage details and applicability notes from this document segment include the following operational points

Product-specific dosing and availability: Adcirca/Alyq: dosing 40 mg PO once daily (maximum 40 mg/day); tablet strength 20 mg. Tadliq: dosing 40 mg (10 mL) PO once daily (maximum 40 mg/day); oral suspension concentration 20 mg/5 mL in a 150 mL bottle.

From Dosage and Product Availability sections.

Policy applicability and brand clarification: Criteria apply to brand Adcirca, Alyq, and Tadliq; policy redirects brand Adcirca or Alyq requests to generic tadalafil where applicable. Tadliq (oral suspension) is included in the policy and may be used when the member is unable to swallow tablets or when generic tablet use is contraindicated or not tolerated.

See policy revision history and prior authorization applicability.

Approval duration and quantity limits: Medicaid and HIM initial approval duration for this maintenance medication was extended from 6 months to 12 months. Requests must not exceed the health-plan approved quantity limit; requests exceeding quantity limits may be subject to denial. A step therapy bypass for IL HIM was added per IL HB 5395.

Coverage for uses of tadalafil that are not FDA‑approved for pulmonary arterial hypertension is not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid).

During the 1Q 2024 annual review commercially unavailable branded products were removed from Appendix B; these items are no longer considered in the Appendix B listings for product availability and therapeutic alternatives.

Requests for tadalafil for non‑FDA approved indications that lack sufficient documentation of efficacy and safety will not be authorized and should be handled per the applicable off‑label use policy (see CP.CPA.09, HIM.PA.154, and CP.PMN.53).

Operational and administrative updates (such as clarifications to product applicability, dosing updates, and Appendix B revisions) are reflected in the policy revision history and should be considered when processing prior authorization requests.

Product Dosing, Availability, and Codes

Product dosing and availability (not billing codes)mixed

Adcirca/Alyq	Tablet: 20 mg; dosing 40 mg PO QD; maximum 40 mg/day
Tadliq	Oral suspension: 20 mg/5 mL in 150 mL bottle; dosing 40 mg (10 mL) PO QD; maximum 40 mg/day; 2 bottles/month or 300 mL/month quantity limit

inv-11: Maximum daily dose — 40 mg/day

Maximum daily dose (Adcirca/Alyq)40 mg/day

Tablet dosing limit2 tablets per day (Adcirca/Alyq)

Dose restriction contextDose must not exceed dosing limits specified in policy for initial and continuation approvals

inv-12: Maximum daily dose — 40 mg/day

Maximum daily dose (Tadliq)40 mg/day (40 mg = 10 mL PO once daily)

Monthly volume limitTadliq maximum 2 bottles/month or 300 mL/month per policy

Dose check for requests

Provider Requirements, Step Therapy, and Documentation

Prior Authorization

Provider Actions and Documentation Requirements

Prior authorization is required for tadalafil products. Requests lacking required documentation may be denied. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria, including diagnosis, specialist involvement, prior therapy/step therapy, and dosing/quantity limits.

Prior authorization required for tadalafil, Adcirca, Alyq, and Tadliq (branded requests may be redirected to generic tadalafil).
Documentation must include evidence of PAH diagnosis, consultation or prescribing by a cardiologist or pulmonologist, and prior calcium channel blocker (CCB) failure or documented contraindication/inadequate response to vasoreactivity testing when applicable.
For initial approvals, failure of a CCB is required unless contraindicated or inadequate response to acute vasoreactivity testing.
For continuation approvals, documentation that the member is responding positively to therapy or meets continuity of care provisions is required.
Step therapy: member must have failed a CCB (see Appendix B for therapeutic alternatives) unless meeting exceptions noted above.
Illinois (HIM) requests: step therapy bypass applies for Tadliq per IL HB 5395 — step therapy requirements do not apply to Tadliq for IL HIM.
Requests for brand Adcirca, Alyq, or Tadliq require use of generic tadalafil unless contraindication, clinically significant adverse effects, or inability to swallow tablets (for Tadliq) are documented.

Background

Tadalafil is a phosphodiesterase‑5 (PDE‑5) inhibitor and is FDA‑approved to improve exercise ability in pulmonary arterial hypertension (PAH; WHO Group 1). The policy applies to formulations marketed as Adcirca, Alyq, and the oral suspension Tadliq, and prior authorization criteria require documentation of the PAH diagnosis and specialty prescriber involvement.

Key Definitions

inv-22: PAH / WHO Group 1 definition — Pulmonary arterial hypertension; indication for tadalafil products

DefinitionPulmonary arterial hypertension (PAH) — WHO Group 1; condition for which tadalafil (Adcirca, Alyq, Tadliq) is FDA‑approved to improve exercise ability.

Clinical contextPAH is managed with targeted agents including PDE5 inhibitors (eg, tadalafil) as part of WHO Group 1 therapy.

Policy implicationApproval criteria apply when diagnosis is PAH (WHO Group 1) and other prior authorization requirements are met.

inv-23: CCB — Calcium channel blocker; listed therapeutic alternatives in Appendix B used in vasoreactivity testing context

TermCalcium channel blocker (CCB)

Role in therapyCCBs are required as step therapy prior to tadalafil for vasoreactive PAH unless inadequate response to acute vasodilator testing or contraindication/adverse effects occur.

Policy Summary

PayerCentene

PolicyTadalafil (Adcirca, Alyq, Tadliq) — Coverage Criteria for PAH

Policy CodePolicy CP.PHAR.198

Change TypeMaterial updates: new formulation, dosing updates, IL HIM bypass, approval duration changes

Effective Date

Next Review Date

SourceLink

On This Page

See policy changes and denial risks.

Requests for dose increases must not exceed the dosing limits specified for Adcirca/Alyq and Tadliq

Requests that exceed health-plan approved quantity limits or exceed specified dosing limits may be denied.

If requesting a dose increase, documentation must support the new dose does not exceed policy dose limits: Adcirca/Alyq ≤40 mg/day and ≤2 tablets/day; Tadliq ≤2 bottles/month and ≤300 mL/month.

Denial Risk

Risk of Denial for Missing Documentation

Missing or incomplete documentation is a common reason for denial. Ensure submitted records clearly show diagnosis, specialist consultation, prior CCB trial or documented exception, response to therapy for continuation, and that the requested product, dose, and quantity are within plan limits.

Absent PAH diagnosis or lack of specialist involvement may lead to denial.
No documentation of CCB failure or documented contraindication/inadequate vasoreactivity response may lead to denial for initial requests.
If branded product is requested without justification for not using generic tadalafil, the request may be redirected or denied.
Requests exceeding plan quantity or dose limits will be denied.

Documentation Required

Required Clinical Documentation

When submitting a PA, include office notes, labs, vasoreactivity testing results (if applicable), medication history showing prior CCB use or reason for bypass, and rationale for branded product if generic tadalafil is not used.

Include documentation of specialist (cardiologist or pulmonologist) involvement or consultation.
Provide evidence of response to therapy for continuation (clinical notes showing improvement or stabilization).
For Tadliq requests in Illinois HIM, document eligibility for the step therapy bypass per IL HB 5395 if applicable.

Step Therapy

Step Therapy Requirement (CCB)

Step therapy applies: initial approval for PAH requires failure of a calcium channel blocker unless contraindicated or inadequate response to acute vasoreactivity testing. Appendix B lists CCB therapeutic alternatives and dosing regimens.

Failure of a CCB is required unless there is documented contraindication or inadequate response to vasoreactivity testing.
Appendix B provides preferred alternative CCB agents and dosing (e.g., nifedipine, diltiazem, amlodipine).

Step Therapy

Step Therapy Bypass — Illinois (HIM)

Per 1Q 2026 updates, IL HIM requests for Tadliq have a statutory step therapy bypass (IL HB 5395).

IL HIM: step therapy requirements do not apply to Tadliq per IL HB 5395.

Billing Rule

Branded Product Redirection

Requests for branded Adcirca, Alyq, or Tadliq may be redirected to generic tadalafil unless there is documentation of contraindication, clinically significant adverse effects, or inability to swallow tablets (Tadliq).

Branded-to-generic redirection applies to Adcirca and Alyq; Tadliq has additional swallowability consideration.
Document clinical justification when requesting branded product to avoid redirection.

Listed therapeutic alternativesAppendix B examples include nifedipine, diltiazem, and amlodipine (specific dosing and maximums are listed in Appendix B).

inv-24: Tadliq — oral suspension formulation details (20 mg/5 mL, 150 mL bottle; dosing 40 mg = 10 mL once daily)

Formulation and concentrationTadliq oral suspension: 20 mg/5 mL in a 150 mL bottle.

Standard dosingDosing listed as 40 mg (10 mL) PO once daily.

Quantity limitPolicy specifies Tadliq maximum 2 bottles/month (300 mL/month).

Brand handling noteTadliq included in policy; for Tadliq requests, step therapy requirements may be bypassed for Illinois HIM per IL HB 5395 and Tadliq permitted when member unable to swallow tablets.